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Background <p>This study aims to evaluate the effectiveness and real-world applicability of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer (LARC), focusing on pathological complete response (pCR) and disease-free survival (DFS) across different chemotherapy regimens.</p> Methods <p>In this multicenter retrospective study, patients treated between January 2019 and January 2023, 437 patients with locally advanced rectal cancer who underwent total neoadjuvant therapy followed by surgery were analyzed. Standard fluoropyrimidine-based chemotherapy regimens (CAPOX, FOLFOX, or FOLFIRINOX) were used according to institutional practice, and long-course chemoradiotherapy constituted the predominant radiotherapy approach. Patients were grouped based on chemotherapy sequencing as induction, consolidation, or sandwich regimens. Outcomes were evaluated using multivariable logistic regression for pathological complete response and Kaplan–Meier analysis with Cox proportional-hazards modeling for disease-free survival. The median follow-up duration was 66&#xa0;months.</p> Results <p>The overall pCR rate was 26.3% (n = 115). pCR rates did not differ significantly between induction, sandwich, and consolidation chemotherapy regimens. A longer interval (&gt; 8&#xa0;weeks) between radiotherapy and surgery was associated with a higher likelihood of achieving pCR. In contrast, cT4 disease and baseline CEA levels &gt; 3&#xa0;ng/mL were associated with lower pCR rates.The estimated 3-year disease-free survival (DFS) rate was 83.8%. Recurrence rates within 3&#xa0;years were numerically higher in patients receiving induction and sandwich regimens compared with consolidation chemotherapy, although these differences did not reach statistical significance. In multivariable analysis, poor tumor regression grade, ypT4 stage, ypN + disease, and post-TNT CEA ≥ 3&#xa0;ng/mL were independently associated with an increased risk of recurrence.</p> Conclusion <p>TNT is effective and feasible in real-world settings, achieving pCR and DFS outcomes comparable to clinical trials. No statistically significant differences were observed in pCR or recurrence rates between induction, consolidation, and sandwich chemotherapy regimens. Prospective phase III trials are needed to compare DFS and OS outcomes across these treatment strategies.</p>

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Real-world effectiveness of total neoadjuvant therapy in locally advanced rectal cancer: a multicenter retrospective study

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  • 发表日期：

    2026年3月23日

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  • Osman Sütcüoğlu,
  • Orhun Akdoğan,
  • İlknur Deliktaş Onur,
  • Atilla Çiftçi,
  • Ali Alkan,
  • Nargiz Majidova,
  • Elif Şahin,
  • Gül Sema Yıldıran,
  • Elif Şenocak Taşçı,
  • Gözde Kavgacı,
  • Ömer Genç,
  • Mehmet Sıddık Dilek,
  • Nilgün Özbek Okumuş,
  • Fariz Emrah Özkan,
  • Oğuzhan Selvi,
  • Hasibe Bilgi Gür,
  • Serhat Sekmek,
  • Fatih Karataş,
  • Şafak Yıldırım Dişli,
  • Nilüfer Avcı,
  • Serkan Menekşe,
  • Mert Erciyestepe,
  • Engin Kut,
  • Süleyman Alkan,
  • Mustafa Ersoy,
  • Ali İnal,
  • Ali Murat Tatlı,
  • Ferit Aslan,
  • Emine Türkmen,
  • Didem Çolpan Öksüz,
  • Teoman Şakalar,
  • Sabin Göktaş Aydın,
  • Gülhan Özkanlı,
  • Abdullah Sakin,
  • Bahiddin Yılmaz,
  • Ali Kaan Güren,
  • Musa Barış Aykan,
  • Fahriye Tuğba Köş,
  • Murat Araz,
  • Atike Pınar Erdoğan,
  • İlhan Hacıbekiroğlu,
  • İbrahim Yıldız,
  • Muhammet Ali Kaplan,
  • Hacer Demir,
  • Suayib Yalçın,
  • Ömer Dizdar,
  • Özgür Tanrıverdi,
  • Dılşa Mızrak Kaya,
  • Mutlu Doğan,
  • Nuriye Özdemir

摘要

Background

This study aims to evaluate the effectiveness and real-world applicability of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer (LARC), focusing on pathological complete response (pCR) and disease-free survival (DFS) across different chemotherapy regimens.

Methods

In this multicenter retrospective study, patients treated between January 2019 and January 2023, 437 patients with locally advanced rectal cancer who underwent total neoadjuvant therapy followed by surgery were analyzed. Standard fluoropyrimidine-based chemotherapy regimens (CAPOX, FOLFOX, or FOLFIRINOX) were used according to institutional practice, and long-course chemoradiotherapy constituted the predominant radiotherapy approach. Patients were grouped based on chemotherapy sequencing as induction, consolidation, or sandwich regimens. Outcomes were evaluated using multivariable logistic regression for pathological complete response and Kaplan–Meier analysis with Cox proportional-hazards modeling for disease-free survival. The median follow-up duration was 66 months.

Results

The overall pCR rate was 26.3% (n = 115). pCR rates did not differ significantly between induction, sandwich, and consolidation chemotherapy regimens. A longer interval (> 8 weeks) between radiotherapy and surgery was associated with a higher likelihood of achieving pCR. In contrast, cT4 disease and baseline CEA levels > 3 ng/mL were associated with lower pCR rates.The estimated 3-year disease-free survival (DFS) rate was 83.8%. Recurrence rates within 3 years were numerically higher in patients receiving induction and sandwich regimens compared with consolidation chemotherapy, although these differences did not reach statistical significance. In multivariable analysis, poor tumor regression grade, ypT4 stage, ypN + disease, and post-TNT CEA ≥ 3 ng/mL were independently associated with an increased risk of recurrence.

Conclusion

TNT is effective and feasible in real-world settings, achieving pCR and DFS outcomes comparable to clinical trials. No statistically significant differences were observed in pCR or recurrence rates between induction, consolidation, and sandwich chemotherapy regimens. Prospective phase III trials are needed to compare DFS and OS outcomes across these treatment strategies.